Contract Senior Clinical Data Manager | South San Francisco, CA
||Senior Clinical Data Manager
||South San Francisco
||Clinical Data Management
|| Up to 10%
Role and Responsibilities
- Work concurrently on multiple data management projects with little to no guidance from Project Data Manager.
- Assist in reviewing/writing/editing sections of the Data Management Plan and eCRF Completion Guidelines at the direction of the Project Data Manager.
- Provide input and assistance in the design of Case Report Forms (CRFs).
- Ability to assist study specific edit check specifications.
- Reconcile project files, reports, listings and other documents generated in data management against a database for accuracy and completeness of data management processes.
- Assist with the provision of data management reports in support of project team, Clinical Research Associates (CRAs), investigative sites and sponsor as requested.
- Describe and demonstrate data review processes to sponsors and auditors when needed.
- Perform all tasks to relevant SOPs, ICH or other regulatory guidelines in DM.
- Provide guidance and training to Level 1 and 2 CDM colleagues as well as new hires.
- Perform other duties as required by the Department.
Bachelor degree in biological science or a related discipline in the science/healthcare field or equivalent education.
Minimum 5+ years of experience in CDM or Biostatistics in a CRO or pharmaceutical industry, or an equivalent combination of education and experience to successfully perform key responsibilities of the job.
- Thorough knowledge of all technical elements of data management.
- Understanding of ICH-GCP principles.
- Thorough understanding of medical terminology and clinical research terminology.
- Varied therapeutic area experience.
- Demonstrated ability to provide coaching and training to new hires and less- experienced colleagues.
- Communicates effectively through both written and verbal methods.
- Manages time effectively to produce quality deliverables in the expected timeframe.